BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 3870038 · Received April 28, 2014

    Report

    Report Number
    2023050-2014-00167
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Report Date
    March 31, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) ASSISTED THE USER FACILITY WITH TROUBLESHOOTING THE DEVICE VIA PHONE. THE VENTILATOR WAS RETURNED TO THE MFR, BY THE USER FACILITY, FOR FURTHER FAILURE ANALYSIS. THE DEVICE WAS FOUND TO HAVE EXPERIENCED A DEFECTIVE TOP MEMBRANE. THE TOP MEMBRANE WAS REPLACED WITHOUT FURTHER INCIDENT. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT THE DOWN ARROW BUTTON WAS UNRESPONSIVE. PT INVOLVEMENT IS UNK. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254045 HT70 PLUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1